BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINKSYMPHOKNEE

    MDR report key: 14432152 · Received May 18, 2022

    Report

    Report Number
    3006721341-2022-00003
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    April 11, 2022
    Report Date
    April 26, 2022
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED COMPLAINT DESCRIPTION: A SAMPLE WAS RECEIVED BY THE SALES REP ON 20220531, WHICH WAS THE EXPLANTED INSERT FROM THE (B)(6) 2022 REVISION SURGERY (ORIGINALLY REPORTED TO BE DONE ON (B)(6) 2022). THE ITEM AND LOT NUMBER ARE 880-227/10, LOT # 1949228 NOT THE PART NUMBER AND LOT NUMBER PREVIOUSLY REPORTED (880-213/14, LOT 2018092). CORRECTED PRODUCT IMPLANTATION AND EXPLANATION DATE AND PATIENT INFORMATION.

    Description of Event or Problem · 0

    PER SALES REP " THE POLY SEEMED TO DISASSOCIATE FROM THE TIBIAL BASED OFF RADIOGRAPH TAKEN ON APPROX. (B)(6) 2022. THIS HAS NOT BEEN CONFIRMED VIA SURGICAL INTERVENTION AT THIS MOMENT. SURGEON NOTIFIED SALES REP THAT THE PATIENT IS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2022".

    Description of Event or Problem · 0

    PER SALES REP " THE POLY SEEMED TO DISASSOCIATE FROM THE TIBIAL BASED OFF RADIOGRAPH TAKEN ON APPROX. APRIL 11TH, 2022. THIS HAS NOT BEEN CONFIRMED VIA SURGICAL INTERVENTION AT THIS MOMENT. SURGEON NOTIFIED SALES REP THAT THE PATIENT IS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2022". UPDATED 20220602: A SAMPLE WAS RECEIVED BY THE SALES REP ON 20220531, WHICH WAS THE EXPLANTED INSERT FROM THE (B)(6) 2022 REVISION SURGERY (ORIGINALLY REPORTED TO BE DONE ON (B)(6) 2022). THE ITEM AND LOT NUMBER ARE 880-227/10, LOT # 1949228 NOT THE PART NUMBER AND LOT NUMBER PREVIOUSLY REPORTED (880-213/14, LOT 2018092).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502021 LINKSYMPHOKNEE ARTICULATING SURFACES, PS+ KRO WALDEMAR LINK GMBH & CO. KG 880-227/10 1949228
    2812946 LINKSYMPHOKNEE ARTICULATING SURFACES, PS+ KRO WALDEMAR LINK GMBH & CO. KG 880-227/10 1949228

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention